FDA refuses to recall devices linked to superbug infections
It may be one of the most underhanded and dangerous things the FDA has ever done.
And, believe me, that’s saying something.
For months I’ve been warning you about a major health crisis involving surgical scopes.
They’re used to give surgeons a better look inside your body – and some of them are filthier than a gas station bathroom.
In fact, these scopes have now been linked to deadly superbug infections all across America.
Now the FDA is defying Congress and is refusing to pull equipment off the market that may have helped cause the outbreaks.
It’s a move that puts patients everywhere at risk – and the FDA is doing everything it can to hide its real motives.
“This may be unprecedented in the history of medical device regulation.”
That’s what scientist Lawrence Muscarella had to say about the FDA’s recent decision to let Custom Ultrasonics’ scope-cleaning machines stay on the market.
You see, Muscarella is the former director of infection control at Custom Ultrasonics — and he was so concerned about safety problems with the equipment that he left the company.
And while Muscarella was fortunate enough to distance himself from Custom Ultrasonics scope cleaners, lots of patients weren’t so lucky.
The company’s equipment is used in hospitals all across the country to clean scopes in between uses. But a Senate investigation in January found that they seem to clean about as well as a maid at a cheap hotel.
According to the Senate report, 9 of the 16 U.S. hospitals with superbug outbreaks linked to scopes were using Custom Ultrasonics equipment. The report even said that it was clear the equipment “played a significant role” in allowing the scopes to “remain contaminated between uses.”
The FDA even ordered Custom Electronics’ System 83 Plus machines off the market, accusing the company of repeated safety violations that put patients at risk.
Case closed, right? Yeah, not exactly.
The FDA just announced last week that it was reversing course and that hospitals could keep using the machines while Custom Ultrasonics sorted out its problems.
Are you kidding me? What is there to sort out? The machines either work or they don’t – and there’s enough evidence now to raise some serious red flags.
So why exactly is the FDA stopping its own recall and ignoring a Senate investigation?
Well, that’s the million-dollar question. The FDA is claiming it received some new information from Custom Ultrasonics – but nobody at the agency will say exactly what that information is.
Have you ever seen such arrogance in your life? The FDA is potentially putting all of us in harm’s way – and they don’t think we’re owed a decent explanation why.
It looks like there was some serious arm-twisting going on, and the FDA, as expected, folded under pressure.
We know by now that we can’t expect the FDA to protect us. But there are two things we can all do right now to keep ourselves safe – and to hold the agency accountable.
1) When you’re going in for a surgery, the last thing you think to ask about is how the scopes are cleaned. But with all the infections we’re seeing, it’s a fair question. Experts recommend looking for a facility that sterilizes its scopes with peracetic acid between patients.
2) Write your members of Congress and demand that they investigate why the FDA suddenly scrapped its recall of Custom Ultrasonics scope cleaners.
Because the FDA is doing its best to keep us in the dark. But it’s high time we started getting some answers.
Sources:
“FDA retreats from recall of scope-cleaning machines” Chad Terhune, May 6, 2016, The Los Angeles Times, latimes.com
